VOYAGER COMPACT IMAGING SYSTEM

K092182 · Ardent Sound, Inc. · IYO · Oct 9, 2009 · Radiology

Device Facts

• Record ID: K092182
• Device Name: VOYAGER COMPACT IMAGING SYSTEM
• Applicant: Ardent Sound, Inc.
• Product Code: IYO · Radiology
• Decision Date: Oct 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Evaluating Soft Tissue by Ultrasound Imaging, using B-mode and M-mode: for Fetal, Abdominal, 3-D Visualization (non measuring), Small organ (thyroid and breast), Musculoskeletal (Conventional), Peripheral Vessel, Transvaginal, Transrectal and Needle Guidance.

Device Story

Voyager Compact Imaging Device is a portable, software-controlled diagnostic ultrasound system. It processes ultrasonic signals from mechanical sector-scan probes (C4, C10, EC) to generate B-mode and M-mode images. The system includes non-metrological 3D rendering and needle guidance support. Operated by clinicians in clinical settings, the device provides real-time visual feedback to assist in diagnostic evaluation and interventional procedures. The system consists of a small in-line ultrasound engine with an 'image-freeze' button, connecting to a laptop for display and control. Output images assist healthcare providers in assessing soft tissue anatomy and guiding needle placement, potentially improving diagnostic accuracy and procedural safety.

Clinical Evidence

Bench testing only. Compliance with acoustic output standards (AIUM/NEMA/IEC) and biocompatibility (ISO 10993-1) was verified. No clinical data was required as the indications for use are not novel.

Technological Characteristics

Portable ultrasound system; mechanical single-crystal sector scan probes (4 MHz and 8 MHz). Materials: Silicone elastomer, HDPE, polyurethane, PVC, ABS, acrylic-based photopolymer. Connectivity: Laptop-based software control. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, ISO 10993-1. Software-controlled engine.

Indications for Use

Indicated for soft tissue ultrasound imaging in fetal, abdominal, small organ (thyroid/breast), musculoskeletal, peripheral vessel, transvaginal, and transrectal applications, including needle guidance. For prescription use only.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Tringa 50S (K020112)
• AU5 (K980468)
• AU5/3D (K000681)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for "ARDENT SOUND". The word "ARDENT" is in large, bold, black letters, with a horizontal line underneath. Below the line, the word "SOUND" is written in a smaller font, flanked by three curved lines on each side, resembling sound waves.

K092182

# 510(k) Summary:

OCT - 9 2009

This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21 CFR, part 807, Subpart E, Section 807.92 using FDA Guidance Document: "Information for Manufacturers Seeking Marketing Clearance for Ultrasound Systems and Transducers", September 09, 2008.

This submission includes the addition of M-Mode Capabilities and an Endocavity probe (for Transvaginal and Transrectal Imaging) to the Voyager Compact Imaging System (K050551)

Company Name: Company Address:

Ardent Sound Inc. 33 S. Sycamore Street Mesa, AZ 85202-1150 USA

| | Corresponding Official: | |
|--|-------------------------|--|
| | | |
| | | |

| E-mail: | |
|----------------------|--|
| Telephone: | |
| Facsimile: | |
| Date of preparation: | |

Deborah Van Gorder Quality Specialist d. [e-mail] 480-649-1806 480-649-1605 March 18, 2009

2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/Usual Name: Diagnostic Ultrasound System with Accessories

Proprietary Name:

Voyager Compact Imaging Device

# Classification: Regulatory Class II

Review Category: Tier II

| | 21 CFR# | Prod. Code |
|---------------------------------------|----------|------------|
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | PC 90-IYO |
| Diagnostic Ultrasonic Transducer | 892.1570 | PC 90-ITX |

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33 South Sycamore Street · Mesa, Arizona 85202 USA · Tel: [phone] · Fax: [phone]

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### Substantial equivalence claimed to:

| Trade Name | Manufacturer | 510(k) |
|------------|--------------|---------|
| Tringa 50S | Pie Medical | K020112 |
| AU5 | Esaote | K980468 |
| AU5/3D | Esaote | K000681 |

The Voyager is of comparable type and substantially equivalent to the legally marketed Pie Medical 50s Tringa, Esaote AU5 Ultrasound Imaging System. AU5 with 3D Imaging Mode. It has the same technology characteristics, is comparable in kev safety and effectiveness features, and all its intended uses and operating modes are available in the predicative devices.

### Description:

The devices referenced in this submission represent a highly portable, softwarecontrolled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes or deviations from indications for use different from those demonstrated in previously cleared devices, inclusive of the predicate devices so claimed.

The devices included in this submission are as follows:

Voyager Ultrasound System utilizing as hardware and firmware an ultrasound engine contained in a very small in-line enclosure with only an 'image-freeze' control button:

A probe, C-4, of a mechanical configuration providing a single crystal sector scan, or M-mode operation, at an ultrasonic frequency of approximately 4 (±12%) MHz,

A probe, C-10, a mechanical configuration providing a single crystal sector scan, or M-mode operation, at an ultrasonic frequency of approximately 8.0 (±20%) MHz,

A probe EC, a mechanical configuration providing a single crystal sector scan, or M-mode operation, at an ultrasonic frequency of approximately 8,0 (±20%) MHz.

Image /page/1/Figure/10 description: This image is a diagram of a Voyager Probe. The diagram shows the different components of the probe, including the transducer, motor, position sensor, wet module, preamp, filter, probe ID, and probe cable & plug. The diagram also shows the flow of data between the different components, with labels TX and RX.

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Software able to reside in a laptop inclusive of a non-metrological 3-D image rendering capability and, a means to enable the use of needle guidance techniques on each probe model.

# Patient Contact Materials:

The following certified patient contact materials are unchanged in formulation and processing remaining FDA compliant. Declaration of Conformity, section 1.7.3. Biocompatibility data to be maintained in the Design History File, under Documentation Control.

| Trade Name | Generic Material | Biocompatibility data |
|----------------------------------------------|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DOW 732 Multi-<br>Purpose Sealant -<br>Clear | Silicone Elastomer | Complies with FDA Regulation 21 CFR<br>177.2600 for incidental contact with food.<br>National Sanitation Foundation List 51, for<br>direct food contact, and List 61, for use with<br>potable water. Recognized under UL<br>QMFZ2 / 510(k) K003479 |
| HDPE | Polyethylene, High Density | Complies with FDA Regulation 21 CFR<br>177. 1520 for incidental contact with food.<br>Technical Data located in DHF. |
| RP-6405 | Polyurethane Hardener | Biocompatibility tests performed by<br>NamSA, Material passed all ISO-10993-1<br>FDA Requirements. Copy of results<br>maintained in DHF. 510(k) K924458 |
| RP-6401 | Polyurethane | Biocompatibility tests performed by<br>NamSA, Material passed all ISO-10993-1<br>FDA Requirements. Copy of results<br>maintained in DHF. 510(k) K924458 |
| Coaxial Cable | Medical Grade PVC | Coast Wire & Plastic Tech., Inc.<br>Manufacturer certifies ISO-10993-1 FDA<br>Compliant #60-0600-24. Technical Data<br>located in DHF |
| Absylux | ABS Acrylonitrite-butadiene-<br>styrene | Westlake Plastics Compangy Manufacturer<br>certifies ISO-10993-1 FDA Compliant #60-<br>0600-24. Technical Data located in DHF |
| FullCure 720 | Acrylic-based photpolymer | Objet Geometries, Ltd. Manufacturer<br>certifies ISO-10993-1. Technical Data<br>located in DHF |
| SterAlloy 2463 | Urethane | Napco, Inc. Manufacturer certifies ISO-<br>10993-1. Technical Data located in DHF |
| RentCast-6400-1 | Urethane | Huntsman Advanced Materials America<br>ertifies ISO-10993-1. Technical Data located<br>in DHF |

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### Voyager complies with the following standards:

- FDA Standards #: 12-66 AIUM "Medical Ultrasound Standard", Dated 06/01/2004 a)
- FDA Standards #: 12-105 NEMA "Acoustic Output Measurement Standard for Diagnostic b) Ultrasound Equipment", dated 09/01/2004
- FDA Standards #: 12-139 AIUM "Acoustic Output Measurement Standard for Diagnostic C) Ultrasound Equipment", dated 03/31/2006
- FDA Standards #: 12-182 IEC "Medical electrical equipment Part 2-37: Particular requirements for d) the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment", dated 07/3 1/2008
- FDA Standards #: 5-4: IEC 60601-1, Part 1: General requirements for safety. e)
- FDA Standards # 5-35; IEC 60601-1-2, Part 1: General requirements for safety, 2. Collateral standard: f) Electromagnetic compatibility - Requirements and tests.
- FDA Standards # 5-41 IEC 60601-1-4, Part 1: General requirements for safety, 4. Collateral standard: g) Programmable electrical medical systems.
- FDA Standards #: 2-98: ISO 10993-1:2003, "Biological Evaluation of Medical Devices Part 1: h) Evaluation and Testing."

#### Intended use:

The intended uses of this system and its accessories are as follows:

Imaging, using B-mode, M-mode: Fetal, Abdominal, 3-D Visualization (non-measuring), Small organ (thyroid and breast), Musculoskeletal (Conventional), Peripheral Vessel, Transvaginal, Transrectal and Needle Guidance.

### Summary of technological characteristics:

There are no technological characteristics or features or indications for use in this Submission that are not previously evaluated and approved in the predicate devices, nor are there such technologies, features and indications for use not commonly used in the practice of diagnostic ultrasound.

#### Testing:

The Voyager Ultrasound System and its accessories are designed for compliance to all applicable medical devices safety standards, as referenced above. Prior release for manufacturing, all such devices, so designed, are tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in Section 1.5. The additional mode of operation for this system is M-mode. The additional probe is the EC endocavity Probe for Transvaginal and Transrectal imaging with non-measuring 3D and Needle Guidance.

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Acoustic Test Result Summary:

| Probe<br>Model | ISPTA.3<br>[mW/cm2] | TI Type | TI Value | MI | Ipa.3@MImax<br>[W/cm2] |
|----------------|---------------------|---------|----------|------|------------------------|
| C4 | 15.8 | TIS | 0.05 | 0.30 | 21.3 |
| C10* | 27.7 | TIS | 0.01 | 0.45 | 99.7 |
| EC* | 27.7 | TIS | 0.01 | 0.45 | 99.7 |

* C10 and EC Probes utilize the same transducer crystal Configuration

## Conclusion:

Ardent Sound, Inc. believes that the acoustic testing, conformance to the standards listed herein and Ardent's compliance to 21 CFR 820 Good Manufacturing Practices, both confirm and ensure the substantial equivalence with respect to safety and effectiveness to the predicate devices identified.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, rendered in a simple, abstract design. The bird is facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT - 9 2009

Ardent Sound, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K092182

> Trade/Device Name: Voyager Compact Imaging Device Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: September 28, 2009 Received: September 29, 2009

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Voyager Compact Imaging Device, as described in your premarket notification:

Transducer Model Numbers

C4 Probe

C10 Probe

EC Endocavity Probe, Transvaginal and Transrectal

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may

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publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Mr. William Jung at [phone].

Sincerely yours,

Herbert Leun

Janihe M. Morris, Director (Acting) Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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| Document No.: | 9830-0004- | | |
|---------------|-------------------------|-------|----------|
| Date: | 18 March 2009 Revision: | Page: | 10 of 97 |

Voyager^TM Compact Imaging Device; Addition of M-Mode and Endocavity Probe
510(k) Premarket Submission

| <b>Indications for Use Statement</b> | <b>K092182</b> |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if Known): | K050551 (Previous Clearance: B-Mode, Needle Guidance, 3D(non-measuring) imaging on the C4 and C10 Transducers) |
| Device Name: | Voyager Compact Imaging Device |
| Indication for Use: | |
| | The intended uses of this system and its accessories are as follows: |
| | Evaluating Soft Tissue by Ultrasound Imaging, using B-mode and M-mode: for Fetal, Abdominal, 3-D Visualization (non measuring), Small organ (thyroid and breast), Musculoskeletal (Conventional), Peripheral Vessel, Transvaginal, Transrectal and Needle Guidance. |
| | 1. C4 Needle Guide Bracket/Kit (Reusable/Disposable) uses kit K973958 <ol type="a"><li>Disinfect or Sterilize per Protek Medical Specifications</li></ol> 2. C10 Needle Guide Bracket/Kit (Reusable/Disposable) uses kit K973958 <ol type="a"><li>Disinfect or Sterilize per Protek Medical Specifications</li></ol> 3. EC Needle Guide Kit (Disposable) uses kit K971722 & K971115 <ol type="a"><li>Sterile Needle Guide</li><li>Sterile Gel</li><li>Sterile Probe Cover (Non-Latex)</li></ol> 4. EC Needle Guide Kit (Reusable) uses kit K971722 & K971115 <ol type="a"><li>Disinfect or Sterilize per Protek Medical Specifications</li></ol> |
| Prescription Use | ✓ And/Or ______ Over the Counter Use |
| | (21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C) |
| | (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) |
| | Concurrence of CDRH, Office of <i>In Vitro</i> Diagnostic Device Evaluation and Safety (OIVD) |
| Division Sign Off | |
| | Office of <i>In Vitro</i> Diagnostic Device |
| | Evaluation and Safety |
| 510(k) | |
| | Ardent Sound, Inc. 33 S. Sycamore St. Mesa, AZ. 85202 |
| (Division Sign-Off) | |
| | Division of Reproductive, Abdominal, |
| | and Radiological Devices |
| 510(k) Number: | K092182 |
| | ARDENT SOUND, INC. • 33 S. Sycamore St. • Mesa, AZ 85202 USA |
| | Tel [phone] • Fax [phone] |

page 1 of 5
5ARDENT SOUND, INC. • 33 S. Sycamore St. • Mesa, AZ 85202 USA Tel [phone] • Fax [phone] • • • • • •

:

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Image /page/8/Picture/0 description: The image shows the logo for Ardent Sound. The logo features a stylized image of a sound wave on the left, followed by the word "ARDENT" in large, bold letters. Below the word "ARDENT" is the word "SOUND" in parentheses, also in bold letters.

### Appendix 1. Indications for Use System Chart

Previous 510(k) Muther: K050551 (Previous Clearance: B-Mode, Needle Guidance, 3d (non-measuring), imaging on the C4 and C10 transducers)

Intended Use: Intended Use: Evaluating Seft-Fissue by Ultrassound Imaging, using B-mode, & combined BM-mode (non-simultaneous) For Prescription Use Only ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

System:

Voyager Compact Imaging System

... ..............

Transducer : C4, C10, EC

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------|-------------------|---|-----|-----|------------------|---------------------------------------------------------------|---------------------------|
| General<br>(Track I Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined (Specify)<br>B&M-Modes, non-<br>simultaneous Imaging | Other*<br>(Specify)<br>3D |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | ** | N | | | | N | Image: [3D] |
| | Abdominal | Image: [P] | N | | | | N | Image: [P] |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify), | Image: [P] | | | | | | |
| | Breast, Thyroid | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | | | | N | N |
| | Trans-vaginal | N | N | | | | N | N |
| Fetal Imaging<br>& Other | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | Image: [P] | N | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) Needle Guidance | ** | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral vessel | Image: [P] | N | | | | | |
| Vessel | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

* Examples of other modes of operation may include Doppler, 3-D Imaging, Harmonic bypging, TissueMotion Doppler, and Color Velocity Imaging

** Previously cleared by FDA (K050551) in B-Mode. New Submittal for EC Probe.

He Reumage 2 of 5
(Division Sign-Off)

ARDENT SOUND, INC. · 33 S. Sycamore St. · Mesa, AZ Beigigian Reproductive and Radiological De Tel [phone] • Fax [phone]

Fm. 9995-0035

510(k) Number K

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## Appendix 1: Indications for Use Probe Chart, C4 Probe

Previous 510(k) Number: K050551 (Previous Clearance: B-Mode, Needle Guidance, 3d (non-measuring) inaging on the C4 and C10 transducers)

Intended Use: Intended Use: Evaluating Soft Tissue by Ultrasound Thraging;-usiling Benode, & canbined BM-mode (non-simultaneous) For Prescription Use Only

System:

Voyager Compact Imaging System

Transducer: C4 Probe

| Clinical Application | | Mode of Operation | | | | | | | | |
|---------------------------|---------------------------------|-------------------|---|-----|-----|------------------|--------------------------------------------------------------|---------------------------|--|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined (Specify)<br>B&M-Modes, non-simultaneous<br>Imaging | Other*<br>(Specify)<br>3D | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | P | N | | | | N | P | | |
| | Abdominal | P | N | | | | N | P | | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify), | | | | | | | | | |
| | Breast, Thyroid | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| Fetal Imaging | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| & Other | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Specify) Needle Guidance | P | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| Cardiac | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harnonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

lles Keen

(Division Sign-Off) V

510(k) Number

Division of Reproductive, Abdominal, and Radiological Devi

OG2 JARDENT SOUND, INC. • 33 S. Sycamore St. • Mesa, AZ 85202 USA Tel [phone] · Fax [phone]

Fm. 9995-0035

page 3 of 5

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Image /page/9/Picture/15 description: The image shows a logo with the word "ARDENT" in large, bold, sans-serif font. Below the word "ARDENT" is a horizontal line, and below the line is the word "SOUND" in a smaller, sans-serif font, enclosed in triple parentheses on either side. To the left of the word "ARDENT" is a graphic that resembles an ultrasound image.

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Image /page/10/Picture/0 description: The image shows the logo for Ardent Sound. The logo features a stylized sound wave graphic to the left of the word "ARDENT" in a bold, textured font. Below the word "ARDENT" is a horizontal line, and below that is the word "SOUND" enclosed in triple parentheses on either side.

## Appendix 1: Indications for Use Probe Chart, C10 Probe

Previous S10(k) Number: K050551 (Previous Clearance: B-Mode, Needle Guidance, 3d (non-measuring) inaging on the C4 and C10 transducers)

Intended Use: Intended Use: Evaluating Soft Tissue by "Olterasound Imaging, using B-mode, & conbined BM-mode (non-simultaneous) For Prescription Use Only

Voyager Compact: Imaging System with M-Mode System: Transducer: C-10 Probe

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|---------------------------------|-------------------|---|-----|-----|------------------|---------------------------------------------------------------|---------------------------|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined (Specify)<br>B&M-Modes, non-<br>simultaneous Imaging | Other*<br>(Specify)<br>3D | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify), | Image: [P] | | | | | | Image: [P] | |
| | Breast, Thyroid | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| Fetal Imaging | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| & Other | Musculo-skeletal (Conventional) | Image: [P] | | | | | | Image: [P] | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Specify) Needle Guidance | Image: [P] | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| Cardiac | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | Image: [P] | | | | | | | |
| | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging,

Tissue Motion Doppler, and Color Velocity Imaging

Heikeleus

(Division Sign-Off) Division of Reproductive, Abdominal, SOUND, INC. • 33 S. Sycamore St. • Mesa, AZ 85202 USA and Radiological Devices ARDEN iQ2 Tel [phone] • Fax [phone](k) Numbpfm ---------------------------------------------------------------------------------------------------------------------------------------------------------------

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Image /page/11/Picture/0 description: The image shows the logo for Ardent Sound. The logo features a stylized graphic to the left of the word "ARDENT" in large, bold, sans-serif font. Below the word "ARDENT" is a horizontal line, and below that is the word "SOUND" in a smaller, bold, sans-serif font, flanked by curved lines that suggest sound waves.

### Appendix 1:

# Indications for Use Probe Chart, EC Endocavity Probe, Transvaginal & Transrectal

Previous 510 (k) Number : K050551 (Previous Clearance: B-Mode, Needle Guidance, 3d (non-measuring) imaging on the C4 and C10 transducers)

Intended Use: Intended Use: Evaluating Soft Tissue.by Ultrasound Imaging, using B-mode, M-note, & combined BM-mode (non-simultaneous) For Prescription-Use-Only

Voyager Compact Imaging System with M-Mode System: Transducer: : EC Endocavity Probe, Transvaginal and Transrectal

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------|-------------------|---|-----|-----|------------------|---------------------------------------------------------------|--------------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined (Specify)<br>B&M-Modes, non-<br>simultaneous Imaging | Other*<br>(Specify<br>3D |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | | | | N | N |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify), | | | | | | | |
| | Breast, Thyroid | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | | | | N | N |
| | Trans-vaginal | N | N | | | | N | N |
| Fetal Imaging<br>& Other | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) Needle Guidance | N | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

* Examples of other modes of operation may include: A-mode, Ampitude Doppler, 3-D Imaging, Harnonic Imaging, Tissue Motion Doppler, and/Color Velocity Imaging

(Division Sign-Off)
Keen
Division of Reproductive, AbORDENT SOUND, INC. •

510(k) Number

Division of Reproductive, AbdeRMANT SOUND, INC. • 33 S. Sycamore St. • Mesa, AZ 85202 USA and Radiological Devices Tel [phone] • Fax [phone] Fm. . 9995-0035

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